BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 4MM 32GA PEN NEEDLE

    MDR report key: 12961072 · Received December 8, 2021

    Report

    Report Number
    8041187-2021-01029
    Event Type
    Malfunction
    Date Received
    December 8, 2021
    Date of Event
    November 9, 2021
    Report Date
    November 22, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    10885403897511
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0073554. MEDICAL DEVICE EXPIRATION DATE: 2025-04-30. DEVICE MANUFACTURE DATE: 2020-03-13. MEDICAL DEVICE LOT #: 0160124 . MEDICAL DEVICE EXPIRATION DATE: 2025-07-31. DEVICE MANUFACTURE DATE: 2020-06-08 . INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF PAST 12 MONTHS QUALITY NOTIFICATION WAS PERFORMED, AND NO QUALITY NOTIFICATION WAS RAISED ON THE REPORTED DEFECTS. THE COMPLAINT IS UNCONFIRMED AS NO PHOTO / SAMPLES OF THE REPORTED BATCH WERE RECEIVED. THEREFORE, ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT WILL BE RE-OPENED AND RE-INVESTIGATED IF THE PHOTO / SAMPLE IS RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD 4MM 32GA PEN NEEDLES EXPERIENCED 29 CASES OF BEING UNABLE TO DELIVER MEDICATION, AND 29 CASES OF NOT FUNCTIONING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING SEVERAL THAT CLOG DURING THE INJECTION. CONSUMER REPORTED THE NON PATIENT END FELT HARD TO PLACE ONTO THE PEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859865 BD 4MM 32GA PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 8975 SEE H10 10885403897511

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown